Microneedle array unit

ABSTRACT

A microneedle array unit including a microneedle array having a plurality of needle-like protrusions arranged on one surface thereof, a gripping portion provided on a side opposite to the plurality of needle-like protrusions of the microneedle array, and a container configured to accommodate the microneedle array. The container includes an accommodation portion having an opening, a deformable portion disposed on a side opposite to the opening, and a binding portion provided in the accommodation portion of the deformable portion and bound to the gripping portion of the microneedle array. The deformable portion is deformed by receiving an external force in a direction of the opening and presses the microneedle array through the gripping portion, and the microneedle array is pushed out of the accommodation portion by being pressed, and the deformable portion maintains a deformed state and presses the microneedle array.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Continuation Application of and claims thepriority benefit of a prior U.S. application Ser. No. 17/019,368, filedon Sep. 14, 2020, now allowed. The prior application claims priorityunder 35 U.S.C § 119 to Japanese Patent Application No. 2019-174153filed on Sep. 25, 2019. The above application is hereby expresslyincorporated by reference, in its entirety, into the presentapplication.

BACKGROUND OF THE INVENTION 1. Field of the Invention

The present invention relates to a microneedle array unit.

2. Description of the Related Art

In recent years, a microneedle array (micro-needle array) has been knownas a new dosage form that enables administration of drugs such asinsulin, vaccines, and human growth hormones (hGH) into the skin withoutpain. Each microneedle of a microneedle array is pierced into the skinby attaching biodegradable microneedles containing a drug to the skin,and these microneedles are absorbed in the skin so that the drugcontained in each microneedle is administered into the skin.

In order to use a microneedle array safely and conveniently, it isdesired that a user can perform a treatment directly without holding themicroneedle array by hand by attaching the microneedle array to acontainer or a puncture device.

As one method of attaching a microneedle array to a container or apuncture device, a method of integrally molding a support with amicroneedle array in a case of molding the microneedle array andattaching the microneedle array to a container or a puncture deviceusing this support is performed. For example, JP2017-070390A describesthat a sheet portion of a transdermal absorption sheet has a sheet-likemesh structure. WO2010/140401A describes a microneedle array formed bybringing a porous support into contact with the surface of a basematerial liquid before a step of drying the base material liquid andimpregnating the porous support with the base material liquid so thatthe support and the microneedle array are integrated with each other.

SUMMARY OF THE INVENTION

However, since the mesh structure used in the transdermal absorptionsheet described in JP2017-070390A is formed in a lattice shape, the meshstructure does not contract even in a case where the microneedle arraycontracts due to drying. Therefore, there is a problem in that themicroneedle array is broken and damaged. Further, as in the microneedlearray described in WO2010/140401A, there is a problem in that it takestime to dry the base material liquid in a case where the support isbrought into contact with the surface of the base material liquid.

Further, as another method of attaching a microneedle array to acontainer and a puncture device, a method of providing a mechanism inwhich a microneedle array is fixed with a pressure sensitive adhesive ora mechanism in which a microneedle array is held by a container and apuncture device is performed. However, in a case where a microneedlearray is fixed the pressure sensitive adhesive, components of thepressure sensitive adhesive are eluted to the microneedle array.Accordingly, there is a concern of safety for a living body. Further, ina case where the mechanism in which the microneedle array is held by acontainer and a puncture device is provided, the structures of thecontainer and the puncture device are complicated. Accordingly, there isa concern that the cost increases and puncture properties are impaireddue to the holding mechanism.

The present invention has been made in consideration of theabove-described circumstances, and the present invention provides amicroneedle array unit which enable reduction of a drying time andprevention of breakage of the microneedle array during drying even in acase where a support mounted on a container or a puncture device isintegrally molded with the microneedle array.

The present invention provides a microneedle array unit comprising: amicroneedle array having a plurality of needle-like protrusions arrangedon one surface thereof; a gripping portion provided on a side oppositeto the plurality of needle-like protrusions of the microneedle array;and a container configured to accommodate the microneedle array. Thecontainer includes an accommodation portion having an opening, adeformable portion disposed on a side opposite to the opening, and abinding portion provided in the accommodation portion of the deformableportion and bound to the gripping portion of the microneedle array. Thedeformable portion is deformed by receiving an external force in adirection of the opening and presses the microneedle array through thegripping portion, and the microneedle array is pushed out of theaccommodation portion by being pressed, and the deformable portionmaintains a deformed state and presses the microneedle array.

According to the present invention, in a case where the beam portion ofthe support member is made to be deformable toward the center of thesheet portion, the beam portion can be deformed by following contractionof the sheet portion in a case of drying the sheet portion in theproduction of the microneedle array. Therefore, it is possible toprevent breakage of the sheet portion due to the drying. Further, theopening portion of the support member can be enlarged by forming thesupport member with the beam portion in a case of drying the sheetportion, and thus it is possible to prevent the drying from beinginhibited even in a case where the support member is disposed. Inaddition, the support member can be integrally molded with themicroneedle array so that the microneedle array can be attached to acontainer or a puncture device using the gripping portion of the supportmember, and thus a user can use the microneedle array safely andconveniently without directly touching the sheet portion and theneedle-like protrusions.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 2 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 3 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 4 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 5 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 6 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 7 is a step view illustrating a procedure for producing amicroneedle array.

FIG. 8 is a perspective view of a support member.

FIG. 9 is a perspective view of a microneedle array.

FIG. 10 is another step view illustrating a procedure for producing amicroneedle array.

FIG. 11 is another step view illustrating a procedure for producing amicroneedle array.

FIG. 12 is another step view illustrating a procedure for producing amicroneedle array.

FIG. 13 is another step view illustrating a procedure for producing amicroneedle array.

FIG. 14 is a perspective view illustrating another example of thesupport member.

FIG. 15 is a perspective view illustrating still another example of thesupport member.

FIG. 16 is a perspective view illustrating still another example of thesupport member.

FIG. 17 is a perspective view illustrating still another example of thesupport member.

FIG. 18 is a perspective view illustrating a microneedle array producedusing the support member illustrated in FIG. 17 .

FIG. 19 is a perspective view illustrating a microneedle array unit.

FIG. 20 is a cross-sectional view of the microneedle array unitillustrated in FIG. 19 .

FIG. 21 is a view for describing a step of puncturing the skin with amicroneedle array.

FIG. 22 is a view for describing a step of puncturing the skin with amicroneedle array.

FIG. 23 is a view for describing a step of puncturing the skin with amicroneedle array.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Hereinafter, a microneedle array and a microneedle array unit accordingto the embodiment of the present invention will be described withreference to the accompanying drawings.

Method of Producing Microneedle Array

FIGS. 1 to 7 are step views illustrating a procedure for producing amicroneedle array. In the production of the microneedle array, first, amold 10 having needle-like depressions 12 is prepared as illustrated inFIG. 1 . For example, the mold 10 can be produced by performing thefollowing steps.

In production of the mold 10, a first mold is formed by performingimprint on a resin precursor from a precursor on which a projectionpattern corresponding to needle-like protrusions of a microneedle arrayto be produced is formed. A duplicate mold is formed by performing anelectroforming treatment after the formation of the first mold. Next, amold sheet having needle-like depressions 12, which is a reverse type ofthe duplicate mold, is formed using a resin film from the duplicatemold. Finally, the mold 10 having needle-like depressions is formed bypunching the mold sheet and then cutting the mold sheet for eachpattern.

As the material of the mold 10, a medical grade silicone material (suchas MDX-4210, manufactured by Dow Corning Corp.), a UV curable resinwhich is cured by irradiation with ultraviolet rays, or a plastic resinsuch as polystyrene or polymethyl methacrylate (PMMA) can be used.

Next, as illustrated in FIG. 2 , a drug layer 110 containing a drug inthe needle-like depressions 12 is formed (drug layer forming step) bysupplying a drug solution to the needle-like depressions 12 (drugsolution filling step) and drying the drug solution. The drug layer 110is formed by coating a region 14 (pattern surface) where the needle-likedepressions 12 have been formed with the drug solution containing thedrug. The coating method is not particularly limited and, for example,the coating can be performed by supplying the drug solution through anozzle. Further, a spot deposition method may be used. After the supplyof the drug solution, the drug solution can be sucked from the rearsurface of the mold 10, and the filling of the needle-like depressions12 with the drug solution can be accelerated.

After the needle-like depressions 12 are filled with the drug solution,the drug solution is dried to form the drug layer 110. The drug is driedby controlling the temperature and humidity conditions to optimize thedrying speed so that adhesion of the drug solution to the wall surfaceof the needle-like depressions 12 can be reduced, and the drying can bepromoted while the drug solution is collected at the tips of theneedle-like depressions 12 by drying the drug solution.

By drying the drug solution, the drug solution is solidified and can bemore contracted than the drug solution in a state of filling theneedle-like depressions. In this manner, the drug layer 110 can beeasily peeled off from the needle-like depressions 12 in a case ofpeeling the microneedle array 120 from the mold 10.

Next, as illustrated in FIG. 3 , a base material liquid 102 is suppliedonto the drug layer 110 containing a predetermined amount of the drug,and the base material liquid 102 is supplied onto the needle-likedepressions 12 and the region 14 where the needle-like depressions 12have been formed (base material liquid filling step). The base materialliquid 102 is a polymer-dissolved solution that forms the base materiallayer 112. The base material liquid 102 can be supplied by coating theregion with the base material liquid using a dispenser or coating theregion with the base material liquid according to a spot depositionmethod, but the present invention is not limited thereto. Since the druglayer 110 is solidified by drying the liquid, diffusion of the drugcontained in the drug layer 110 into the base material liquid 102 can besuppressed.

As illustrated in FIG. 3 , the supply of the base material liquid 102 iscarried out such that at least a part of a stepped portion 16 providedin the periphery of the region 14 where the needle-like depressions 12have been formed is covered with the base material liquid 102. Further,the base material liquid 102 is supplied beyond a contact position 17from a side of the region 14 where the needle-like depressions 12 havebeen formed. The supplied base material liquid 102 is repelled by themold 10 and contracts due to the surface tension. As illustrated in FIG.4 , the contracted base material liquid 102 is fixed (pinned) at thecontact position 17 which is a contact point between the stepped portion16 of the mold 10 and a wall portion 18 formed from the region 14 wherethe needle-like depressions 12 have been formed toward the steppedportion 16. After the base material liquid 102 is supplied, vacuumsuction may be performed from a side of the mold 10 opposite to theregion 14 where the needle-like depressions 12 have been formed. Byperforming the vacuum suction, the needle-like depressions 12 can befilled with the base material liquid 102. Further, in a case wherebubbles are present in the base material liquid 102, the bubbles can beremoved by suction.

Next, as illustrated in FIG. 5 , the support member 50 is placed on thestepped portion 16 of the mold 10 from above the base material liquid102 supplied onto the mold 10 (support member placing step). FIG. 8 is aperspective view illustrating the support member 50. The support member50 comprises a gripping portion 52 that extends in one direction and abeam portion 54 having one end that is connected to a side surface ofthe gripping portion 52. The gripping portion 52 comprises a circularbase portion 51 and a rod-like portion 53 formed in a direction (onedirection) perpendicular to a circular surface of the base portion 51.The end of the rod-like portion 53 on a side opposite to the baseportion 51 has a claw portion 55 that fits into a container in a case ofstoring the microneedle array in the container and fixing themicroneedle array thereto. The beam portion 54 is formed such that oneend thereof is connected to a side surface of the base portion 51 andcurvedly extends from the gripping portion 52 in the diametric directionand the circumferential direction. In FIG. 8 , the gripping portion 52extends in a radial direction with the gripping portion 52 as the centerand is curved in a circumferential direction. The beam portion 54 can bedeformed in the direction (the direction toward the gripping portion 52)indicated by an arrow A shown in the figure by providing the beamportion 54 so as to be curved in the circumferential direction. Further,since the beam portion 54 can be deformed by following contraction dueto drying of the base material liquid 102 in the drying of the basematerial liquid described below by providing the beam portion 54 so asto be curved in the circumferential direction, it is possible to preventbreakage (breakage of the base material layer) due to the drying of thebase material liquid 102. Further, as illustrated in FIG. 5 , since thebeam portion 54 is placed on the stepped portion 16 of the mold 10, thesupport member 50 is provided such that the other end of the beamportion 54 is positioned outside the region 14 where the needle-likedepressions 12 have been formed in a case of placing the support member50 on the mold 10. In addition, the cross section of the support member50 illustrated in FIG. 5 is a cross section taken along the line 5-5shown in FIG. 8 .

FIG. 8 illustrates a configuration in which the base portion 51comprises three rod-like portions 53, but the present invention is notlimited thereto. Further, a configuration in which the claw portion 55is provided at the end by increasing the columnar shape of the baseportion 51 without providing the rod-like portion 53 can be employed.Further, the shape of the base portion 51 is not limited to the circularshape, and a triangular shape or a further polygonal shape can beemployed.

As illustrated in FIG. 4 , the base material liquid 102 is held at aposition higher than the stepped portion 16 due to the surface tension.In this state, at least a part of the beam portion 54, that is, a lowerend 54 a of the beam portion 54 can be buried by placing the supportmember 50 on the stepped portion 16 of the mold 10.

As the material constituting the support member 50, a drug productapplication grade cycloolefin polymer (COP) can be used. Alternatively,a resin such as polyethylene or polypropylene can be used. Further, ametal can be used.

Returning to FIG. 6 , the base material liquid 102 is dried andsolidified (base material layer forming step) after the support member50 is placed on the stepped portion 16 of the mold 10. In this manner,as illustrated in FIG. 6 , the base material layer 112 can be formed onthe drug layer 110 so that the microneedle array 120 having the druglayer 110 and the base material layer 112 is formed. According to thesupport member 50 of the present embodiment, since there is a gapbetween the beam portions 54, it is possible to prevent the delay indrying even in a case of placing the support member 50. Further, in acase where the base material liquid 102 is dried and solidified to formthe sheet portion, an integrally molded body formed by molding thesupport member 50 and the sheet portion integrally with each other canbe obtained. The tip of the gripping portion 52 is provided so as to beexposed from a side of the base material layer 112 opposite to thesurface on which the drug layer 110 has been formed. In this manner, theend thereof can be fixed to the binding portion 318 of the container 310described below.

The base material liquid 102 contracts toward the center of the appliedbase material liquid 102. In a case of placing the support member 50,the support member 50 is placed such that the gripping portion 52 ispositioned at the center of the applied base material liquid 102, thatis, at the center of the region 14 of the mold 10 where the needle-likedepressions 12 have been formed. In this manner, the base materialliquid 102 contracts toward the gripping portion 52 of the supportmember 50. Since the beam portion 54 is formed by being curved in thecircumferential direction and is deformable toward the gripping portion52, the beam portion 54 is deformable toward the center of the basematerial liquid 102, that is, the center of the dried sheet portion. Asdescribed above, by allowing the beam portion 54 to be further curved byfollowing contraction of the base material liquid 102 in a case ofcontraction of the base material liquid 102, it is possible to preventbreakage of the base material layer in a case of drying the basematerial liquid 102.

In the beam portion 54 of the support member 50 and the base materiallayer 112, the contraction force that the base material liquid 102contracts due to the drying of the base material liquid 102 and therestoring force that the beam portion 54 followed by the contractionforce is expected to return to the original state interact with eachother so that the support member 50 and the base material layer 112 areintegrally molded with each other. Further, fine depressions andprotrusions to be molded during the production of the support member 50,projections, and the like are formed on the surface of the beam portion54. The support member 50 and the base material layer 112 can be fixedby the anchor effect in which the base material liquid 102 entersbetween the fine depressions and protrusions, projections, and the like.

The moisture content and the like of the microneedle array 120 due tothe drying are set as appropriate. Further, in a case where the moisturecontent of the base material layer 112 is extremely small due to thedrying, since the microneedle array is unlikely to be peeled off, it ispreferable that the moisture content in a state where the elastic forceis maintained is allowed to remain.

Finally, as illustrated in FIG. 7 , the microneedle array 120 isproduced by peeling the dried microneedle array 120 off from the mold 10(peeling step).

FIG. 9 is a perspective view of the microneedle array as viewed from aside of the needle-like protrusion 44. The produced microneedle array tobe produced comprises a sheet portion 41 formed of the base materiallayer 112, and a plurality of needle-like protrusions 44 arranged on onesurface 42 of the sheet portion 41. In the needle-like protrusion 44,the tip thereof is formed of the drug layer 110 and the base end thereofis formed of the base material layer 112. The needle-like protrusion 44forms a microneedle. The plurality of needle-like protrusions 44 arearranged in a microneedle region 42B inside an outer peripheral surface42A of the one surface 42. As illustrated in FIG. 9 , the boundarybetween the outer peripheral surface 42A and the microneedle region 42Bis an imaginary line 42C connecting the outermost needle-likeprotrusions 44 among the plurality of needle-like protrusions 44.

The shapes and the dimensions of the sheet portion 41 and theneedle-like protrusion 44 may be selected depending on the applicationsof the microneedle array 120. In the embodiment, the example in whichthe sheet portion 41 has a circular shape has been described, but thesheet portion 41 may have a rectangular shape.

The needle-like protrusion 44 has a substantially conical shape, but theneedle-like protrusion 44 may have a columnar shape, a frustum shape, orthe like. In the embodiment, the needle-like protrusion 44 is formed inorder of a truncated cone portion and a cone from the one surface 42toward the tip, but is not particularly limited as long as the skin canbe punctured by the needle-like protrusion. It is preferable that theneedle-like protrusions 44 are arranged in an array in a state wherecolumns (lateral line) and rows (horizontal line) are uniformly spaced.

The sheet portion 41 of the microneedle array 120 has a diameter of, forexample, 10 mm to 30 mm. Further, the needle-like protrusion 44 has alength of, for example, 0.2 mm to 1.5 mm. Further, for example, 4 to1000 needle-like protrusions 44 are arranged on one surface 42 of thesheet portion 41. However, the present invention is not limited to thesevalues.

The gripping portion 52 of the support member 50 is provided to protrudeon a side of the other surface 43 of the microneedle array 120. Thegripping portion 52 functions as a fitted portion to which the bindingportion 318 provided on a deformable portion 314 of the container 310described below is fitted. Further, in a case where the microneedlearray 120 is handled by using the gripping portion 52, since it ispossible to prevent the user from directly holding the needle-likeprotrusions 44 of the microneedle array 120 and the one surface 42 ofthe sheet portion 41 by hand, the microneedle array 120 can be usedsafely and conveniently.

Base Material Liquid

The base material liquid which is a solution in which a polymer resinused in the present embodiment has been dissolved will be described.

As the material of the resin polymer used in the base material liquid,it is preferable to use a resin with biocompatibility. Preferredexamples of such resins include saccharides such as glucose, maltose,pullulan, chondroitin sulfate, sodium chondroitin sulfate, sodiumhyaluronate, and hydroxyethyl starch; proteins such as gelatin; andbiodegradable polymers such as polylactic acid and a lacticacid-glycolic acid copolymer. Although the concentration variesdepending on the material, it is preferable that the concentration ofthe resin polymer in the base material liquid is set to be in a range of10% by mass to 50% by mass. Further, the solvent used for dissolutionmay be any solvent other than warm water as long as it has volatility,and methyl ethyl ketone (MEK), alcohol, or the like can be used.

In a case where a water-soluble polymer (such as gelatin) is used, thebase material liquid can be prepared by dissolving water-soluble powderin water. In a case where the water-soluble powder is unlikely to bedissolved in water, dissolution may be performed by heating water. Thetemperature can be appropriately selected depending on the kind of thepolymer material, but it is preferable to heat water at a temperature ofapproximately 60° C. or lower. The viscosity of the base material liquidis preferably 2000 Pa·s or less and more preferably 1000 Pa·s or less.By appropriately adjusting the viscosity of the base material liquid,the base material liquid can be easily injected into the needle-likedepressions of the mold. The viscosity of the base material liquid canbe measured by, for example, a capillary viscometer, a falling ballviscometer, a rotary viscometer, or a vibration viscometer.

Drug solution

The drug solution forming the drug layer 110 will be described. The drugsolution is a solution in which the base material liquid contains apredetermined amount of drug. Whether or not the base material liquidincludes a predetermined amount of drug is determined based on whetheror not a drug effect can be exhibited at the time of puncturing the bodysurface. Therefore, the expression “including a predetermined amount ofdrug” indicates that the base material liquid contains the drug in anamount that enables exhibition of the drug effect at the time ofpuncturing the body surface.

The drug contained in the drug solution is not limited as long as thedrug has a function as a drug. In particular, it is preferable that thedrug is select from peptides, proteins, nucleic acids, polysaccharides,vaccines, pharmaceutical compounds belonging to water-solublelow-molecular-weight compounds, and cosmetic components.

The concentration of the polymer in the drug solution (the concentrationof the polymer excluding the drug in a case where the drug itself is thepolymer) is preferably in a range of 0% by mass to 30% by mass. Further,the viscosity of the drug solution is preferably 100 Pa·s or less andmore preferably 10 Pa·s or less.

Another Method of Producing Microneedle Array

FIGS. 10 to 13 are step views illustrating another method of producing amicroneedle array. Even in the production method according to thepresent embodiment, first, the mold 10 having the needle-likedepressions 12 is prepared.

Next, as illustrated in FIG. 10 , a polymer-dissolved solution 132 issupplied onto the needle-like depressions 12 and the region 14 where theneedle-like depressions 12 have been formed, and the needle-likedepressions 12 are filled with the polymer-dissolved solution 132(polymer-dissolved solution filling step). As the polymer-dissolvedsolution 132, the above-described base material liquid may be used or apolymer-dissolved solution containing a drug in the base material liquidmay be used. The supply of the polymer-dissolved solution 132 can beperformed in the same manner as the above-described supply of the basematerial liquid illustrated in FIGS. 3 and 4 . That is, thepolymer-dissolved solution 132 is supplied onto the mold 10 so as tocover at least a part of the stepped portion 16, and thepolymer-dissolved solution 132 is fixed at the contact position 17 byusing the contraction due to the surface tension.

Next, as illustrated in FIG. 11 , the support member 50 is placed on thestepped portion 16 of the mold 10 from above the polymer-dissolvedsolution 132 supplied on the mold 10 (support member placing step).Since the polymer-dissolved solution 132 is held at a position higherthan the stepped portion 16 due to the surface tension, at least a partof the beam portion 54, that is, the lower end 54 a of the beam portion54 can be buried by placing the support member 50 on the stepped portion16 of the mold 10.

Next, as illustrated in FIG. 12 , the polymer-dissolved solution 132 isdried and solidified in a state in which the support member 50 is placedon the stepped portion 16 of the mold 10 (polymer layer forming step).In this manner, as illustrated in FIG. 12 , the microneedle array 140 inwhich the polymer layer 134 and the support member 50 are integrallymolded is formed. Even in the present embodiment, since thepolymer-dissolved solution 132 can be dried from the gap between thebeam portions 54, it is possible to prevent the delay in drying.Further, since the beam portion 54 can be deformed by following thecontraction of the polymer-dissolved solution 132, it is possible toprevent breakage of the polymer layer 134 in a case of drying thepolymer-dissolved solution 132.

Finally, as illustrated in FIG. 13 , the microneedle array 140 isproduced by peeling the dried microneedle array 140 off from the mold10.

Other Embodiments of Support Member

FIGS. 14 to 17 are perspective views illustrating other embodiment ofthe support member, and FIG. 18 is a perspective view illustrating amicroneedle array produced using the support member illustrated in FIG.17 .

In a support member 150 illustrated in FIG. 14 , one beam portion 154 isprovided in the gripping portion 52, and the beam portion 154 is formedin a spiral shape.

A support member 180 illustrated in FIG. 15 is formed of eight beamportions 184 while the support member 50 illustrated in FIG. 6 is formedof four beam portions 54.

In a support member 200 illustrated in FIG. 16 , a beam portion 204extending from the gripping portion 52 has a plurality of inflectionpoints and extends outward while changing the curving direction.

Even in the support member illustrated in FIGS. 14 to 16 , the beamportion can be deformed in the contraction direction of the basematerial liquid 102 in a case of drying the base material liquid 102 byforming the beam portion in a curved shape, and thus he beam portion canbe made to follow the contraction direction of the base material liquid.

Further, the support member 230 illustrated in FIG. 17 has a cut-outportion 236 in a beam portion 234. In the cut-out portion 236, the notchis formed in another direction opposite to the one direction in whichthe gripping portion 52 extends. By providing the cut-out portion 236,the cut-out portion 236 can be buried in the base material liquid 102 ina case of placing the support member 230 on the stepped portion 16 ofthe mold 10. As illustrated in FIG. 18 , the support member 230 and thesheet portion can be molded more integrally with each other by buryingdepressions.

Microneedle Array Unit

Next, a microneedle array unit having a microneedle array will bedescribed. The microneedle array unit has a microneedle array and acontainer that accommodates the microneedle array. Further, thecontainer comprises an accommodation portion that accommodates themicroneedle array, and a lid member that seals an opening provided inthe accommodation portion. In the microneedle array unit, a part of thecontainer is deformed by applying an external force from a side oppositeto the opening, the microneedles are pushed out of the container, andthe microneedle array is pressed by the deformed container.

FIG. 19 is a perspective view of the microneedle array unit, and FIG. 20is a cross-sectional view of the microneedle array unit illustrated inFIG. 19 .

As illustrated in FIGS. 19 and 20 , a microneedle array unit 300comprises a container 310. The container 310 comprises an accommodationportion 312 for accommodating the microneedle array 120, a deformableportion 314 integrated with the accommodation portion 312, and a flangeportion 316 which is integrated with the accommodation portion 312 andextends outward from the periphery of an opening 312A.

The accommodation portion 312, the deformable portion 314, and theflange portion 316 of the container 310 have a circular shape in planview. However, the shapes of the accommodation portion 312, thedeformable portion 314, and the flange portion 316 are not limitedthereto. It is preferable that the shapes and the sizes of theaccommodation portion 312 and the deformable portion 314 correspond tothe shape and size of the microneedle array 120. The flange portion 316is a portion that comes into contact with the skin at the time ofpuncturing the skin with the microneedle array 120. The flange portion316 is provided on the entire periphery of the accommodation portion312. The entire periphery indicates that the flange portion 316surrounds the entire circumference of the accommodation portion 312.

As illustrated in FIG. 20 , the accommodation portion 312 has aninternal space defined by an inner wall and the opening 312A. Theopening 312A of the accommodation portion 312 is sealed by the lidmember 330. The accommodation portion 312 is sealed by bringing theperiphery of the lid member 330 into contact with the flange portion316.

The deformable portion 314 is disposed on a side opposite to themicroneedle array 120 in the accommodation portion 312 with respect tothe opening 312A and is integrated with the accommodation portion 312.In the embodiment, for example, the deformable portion 314 is formed ina convex shape with a vertex 314A separated from the microneedle array120. The convex shape indicates that the vertex 314A is not positionedin the internal space of the accommodation portion 312. The term“integrated” indicates a state where the accommodation portion 312 isconnected with the deformable portion 314. For example, in a case wherethe accommodation portion 312 is integrated with the deformable portion314, this integration can be achieved by separately molding theaccommodation portion 312 and the deformable portion 314, fitting theaccommodation portion 312 and the deformable portion 314 to each other,and welding the accommodation portion and the deformable portion. In acase where the accommodation portion 312 is integrally molded with thedeformable portion 314, the integration may be carried out before orafter the accommodation of the microneedle array 120 in theaccommodation portion 312. In the case where the accommodation portion312 is integrated with the deformable portion 314, the integration canbe realized by integrally molding the accommodation portion 312 and thedeformable portion 314. However, the present invention is not limited tothese methods.

The deformable portion 314 may have a frustum shape. In the embodiment,the deformable portion has a conical shape. Further, the deformableportion may have a cone shape such as a pyramid shape, and a frustumshape or a dome shape can be employed. Further, the deformable portion314 may have, for example, an internal space, and the internal space ofthe deformable portion 314 can communicate with the internal space ofthe accommodation portion 312. The accommodation portion 312 has astructure closed by the deformable portion 314 on a side opposite to theopening 312A.

The flange portion 316 is integrated with the accommodation portion 312and comes into contact with the skin as described below. In theembodiment, the flange portion 316 extends outward from a position ofthe opening 312A of the accommodation portion 312. The flange portion316 is formed so as to be parallel to the sheet portion of themicroneedle array 120. The concept of “parallel” includes parallel andsubstantially parallel. As described below, the shape of the flangeportion 316 is not particularly limited as long as the flange portioncomes into contact with the skin. In a case where the accommodationportion 312 is integrated with the flange portion 316, the same methodas in the case where the accommodation portion 312 is integrated withthe deformable portion 314 can be applied.

The binding portion 318 that is bound to the microneedle array 120 andfixes the microneedle array 120 to the container 310 is provided on aside of the accommodation portion 312 of the deformable portion 314. Themicroneedle array 120 is fixed to the container 310 by binding thebinding portion 318 to the gripping portion 52 of the microneedle array120 so that the microneedle array 120 is integrated with the container310. According to the method of binding the binding portion 318 to thegripping portion 52, the microneedle array and the container areintegrated with each other by fitting the claw portion 55 provided inthe gripping portion 52 to a groove 319 provided in the binding portion318. Further, the method of binding the binding portion 318 to thegripping portion 52 is not limited thereto. For example, the groove isprovided in the gripping portion to fix the microneedle array and thecontainer by providing the claw portion in the binding portion. Themicroneedle array 120 and the container 310 are fixed by fitting amember, and the safety for a living body can be ensured by not using anadhesive.

It is preferable that the container 310 constituting the microneedlearray unit 300 is formed of, for example, a polyethylene resin, apolypropylene resin, or a mixture thereof. However, the presentinvention is not limited thereto. It is preferable that each of thesematerials satisfies the “Specification of Aqueous Injection Containermade of Plastic (hereinafter, simply referred to as injection containergrade)” of Japanese Pharmacopoeia. In addition, the container 310 may beformed of various other resin materials satisfying the samespecification.

In particular, a material in which the shape is deformed at the time ofthe deformable portion 314 receiving an external force and the deformedshape is maintained is selected from among these materials. The materialto be used is determined in consideration of the shape and thickness ofthe deformable portion 314, the magnitude of the external force requiredfor deformation, and the like.

According to the microneedle array 120 of the present embodiment,packaging of the microneedle array 120 in a sterile room can be easilyperformed by integrally molding the support member 50 with the sheetportion 41 (base material layer 112). Since the microneedle array 120 isused by puncturing the skin, it is necessary to protect the microneedlesuntil the skin is punctured. Further, in order to ensure the sterilityof the microneedle array 120, the packaging of the microneedle array inthe container 310 is performed in a sterile room, and the microneedlearray is stored in the container 310 until immediately before use. In acase where the microneedle array 120 is not integrated with the supportmember 50, the container 310, the support member 50, and the microneedlearray 120 are separately fixed in a sterile room. Therefore, it takestime to work in a sterile room. Further, members for fixing the supportmember 50 and the microneedle array 120 are also required. By integrallymolding the support member 50 with the sheet portion 41 and by fixingthe support member 50 to the container 310, the microneedle array 120can be fixed to the container 310, and the packaging step in a sterileroom can be simplified. Further, the number of members for fixing thesupport member 50 and the microneedle array 120 can be reduced.

Next, a step of puncturing the skin with the microneedle array 120 usingthe microneedle array unit 300 will be described with reference to FIGS.21 to 23 . FIGS. 21 to 23 are cross-sectional views of the microneedlearray unit 300 illustrating the step of puncturing the skin with themicroneedle array 120.

First, the lid member 330 that seals the opening 312A of theaccommodation portion 312 is peeled off from the container 310. Theneedle-like protrusions 44 of the microneedle array 120 are protectedfrom damage because of the lid member 330. It is preferable that the lidmember 330 has a knob in order to facilitate the peeling.

Next, the container 310 is positioned on a skin 370 as illustrated inFIG. 21 . The opening 312A of the accommodation portion 312 ispositioned toward the skin 370, and the needle-like protrusions 44 ofthe microneedle array 120 are oriented toward the skin 370. The flangeportion 316 extending outward from the accommodation portion 312 isbrought into contact with the skin 370. A finger 360 is positioned at aposition separated from the deformable portion 314 in order to apply anexternal force to the deformable portion 314 in a direction of theopening 312A. The microneedle array 120 is supported by fitting thebinding portion 318 of the container 310 and the gripping portion 52 ofthe support member 50 and is positioned in the internal space of theaccommodation portion 312.

After the container 310 is positioned on the skin 370, the deformableportion 314 is pressed toward the skin 370 by the finger 360. Thedeformable portion 314 is deformed by receiving an external force in adirection of the opening 312A. As illustrated in FIG. 22 , thedeformable portion 314 is deformed by an external force, and thedeformed shape of the deformable portion 314 is maintained even afterthe external force is removed. The deformable portion 314 which has beendeformed presses the microneedle array 120 toward the skin 370.

As described above, the microneedle array 120 is fixed to the container310 by fitting the binding portion 318 provided on the deformableportion 314 and the gripping portion 52 provided on the support member50. Therefore, by pressing the deformable portion 314, the microneedlearray 120 is pushed out of the accommodation portion 312 through thegripping portion 52 in a state where the microneedle array 120 is fixedto the container 310. The microneedle array 120 passes through theopening 312A, and the needle-like protrusions 44 of the microneedlearray 120 puncture the skin 370.

After the puncture, since the microneedle array 120 is pressed by thedeformable portion 314 of the container 310 until the drug of themicroneedle array 120 is administered, falling of the microneedle array120 off the skin 370 without pressing of the finger 360 is prevented.

By designing the outer diameter of the microneedle array 120, that is,the beam portion 54 of the support member 50 to be slightly smaller thanthe inner diameter of the accommodation portion 312, it is possible toprevent the pressed microneedle array 120 from being greatly deviatedfrom a direction of the opening 312A. Therefore, the skin 370 can bevertically punctured by the needle-like protrusions 44 of themicroneedle array 120.

Finally, the microneedle array 120 is peeled off together with thecontainer 310 as illustrated in FIG. 23 . The peeling of the microneedlearray is performed after the skin 370 is punctured by the needle-likeprotrusions 44 of the microneedle array 120 and the time for which thedrug layer 110 forming the needle-like protrusions 44 remains in theskin is elapsed. In this manner, the drug can be injected into the skin.Since the microneedle array 120 is fixed to and integrated with thecontainer 310, the treatment can be performed without separating themicroneedle array 120 and the container 310 from each other even at thetime of puncturing the skin and peeling the microneedle array from theskin. Therefore, separate disposal of the microneedle array 120 and thecontainer 310 is not required at the time of puncturing the skin withthe microneedle array 120, and the disposal can be easily carried out.Further, by disposing of the microneedle array 120 and the container 310together, it is possible to prevent the microneedle array 120 fromremaining on a patient side and improve the safety for the patient.

EXPLANATION OF REFERENCES

-   -   10: mold    -   12: needle-like depression    -   14: region where needle-like depressions have been formed    -   16: stepped portion    -   17: contact position    -   18: wall portion    -   41: sheet portion    -   42: one surface    -   42A: outer peripheral surface    -   42B: microneedle region    -   42C: imaginary line    -   43: other surface    -   44: needle-like protrusion    -   50, 150, 180, 200, 230: support member    -   51: base portion    -   52: gripping portion    -   53: rod-like portion    -   54, 154, 184, 204, 234: beam portion    -   54 a: lower end    -   55: claw portion    -   102: base material liquid    -   110: drug layer    -   112: base material layer    -   120, 140: microneedle array    -   132: polymer-dissolved solution    -   134: polymer layer    -   236: cut-out portion    -   300: microneedle array unit    -   310: container    -   312: accommodation portion    -   312A: opening    -   314: deformable portion    -   314A: vertex    -   316: flange portion    -   318: binding portion    -   319: groove    -   330: lid member    -   360: finger    -   370: skin

What is claimed is:
 1. A microneedle array unit comprising: amicroneedle array having a plurality of needle-like protrusions arrangedon one surface thereof; a gripping portion provided on a side oppositeto the plurality of needle-like protrusions of the microneedle array;and a container configured to accommodate the microneedle array, whereinthe container includes an accommodation portion having an opening, adeformable portion disposed on a side opposite to the opening, and abinding portion provided in the accommodation portion of the deformableportion and bound to the gripping portion of the microneedle array, thedeformable portion is deformed by receiving an external force in adirection of the opening and presses the microneedle array through thegripping portion, and the microneedle array is pushed out of theaccommodation portion by being pressed, and the deformable portionmaintains a deformed state and presses the microneedle array.
 2. Themicroneedle array unit according to claim 1, wherein the binding portionand the gripping portion are fitted and bound to each other.
 3. Themicroneedle array unit according to claim 2, wherein a claw portionprovided in the gripping portion fits to a groove provided in thebinding portion.
 4. The microneedle array unit according to claim 1,further comprising a lid member configured to seal the opening.
 5. Themicroneedle array unit according to claim 1, wherein the deformableportion is formed integrally with the accommodation portion.
 6. Themicroneedle array unit according to claim 1, wherein the deformableportion is formed into a convex shape with a vertex separated from themicroneedle array.
 7. The microneedle array unit according to claim 1,wherein the container comprises a flange portion extending outward froma periphery of the opening of the accommodation portion.